Hexaxim suspension for injection

البلد: أرمينيا

اللغة: الإنجليزية

المصدر: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

العنصر النشط:

diphtheria toxoid, tetanus toxoid, pertussis toxoid/filamentous haemagglutinin, poliovirus types 1/2/3, hepatitis B surface antigen, haemophilus infuenzae type b polysaccharide, haemophilus infuenzae type b polysaccharide conjugated to tetanus protein

متاح من:

Sanofi Pasteur SA

ATC رمز:

J07CA09

INN (الاسم الدولي):

diphtheria toxoid, tetanus toxoid, pertussis toxoid/filamentous haemagglutinin, poliovirus types 1/2/3, hepatitis B surface antigen, haemophilus infuenzae type b polysaccharide, haemophilus infuenzae type b polysaccharide conjugated to tetanus protein

جرعة:

20IU/0.5ml+ 40IU/0.5ml+ 25/25mcg/0.5ml+ 40/8/32 DU/0.5ml+ 10mcg/0.5ml+ 12mcg/0.5ml+ 22-36mcg/0.5ml

الشكل الصيدلاني:

suspension for injection

الوحدات في الحزمة:

(1) pre-filled syringe 0.5ml and (2) needles

نوع الوصفة الطبية :

Prescription

الوضع إذن:

Registered

تاريخ الترخيص:

2019-04-01

خصائص المنتج

1.
NAME OF THE MEDICINAL PRODUCT
Hexaxim suspension for injection in pre-filled syringe
Hexaxim suspension for injection in vial
Diphtheria, tetanus, pertussis (acellular, component), hepatitis B
(rDNA), poliomyelitis (inactivated)
and
Haemophilus influenzae
type b conjugate vaccine (adsorbed).
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose
1
(0.5 ml) contains:
Diphtheria Toxoid
………………………………………………not less than 20
IU
2
Tetanus Toxoid
…………………………………………………not less than
40 IU
2
Bordetella pertussis
antigens
Pertussis Toxoid
……………………………………………….25 micrograms
Filamentous Haemagglutinin…………………………………. 25
micrograms
Poliovirus (Inactivated)
3
Type 1 (Mahoney)
…………………………………………….40 D antigen units
4
Type 2 (MEF-1)………………………………………………..
8 D antigen units
4
Type 3 (Saukett)
……………………………………………….32 D antigen
units
4
Hepatitis B surface antigen
5 ……………………………………………………….
10 micrograms
Haemophilus influenzae
type b polysaccharide…………….. 12 micrograms
(Polyribosylribitol Phosphate)
conjugated to Tetanus protein……………………………….
22-36 micrograms
1
Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al
3+
)
2
As lower confidence limit (p= 0.95)
3
Produced on Vero cells
4
Or equivalent antigenic quantity determined by a suitable
immunochemical method
5
Produced in yeast
Hansenula polymorpha
cells by recombinant DNA technology
The vaccine may contain traces of glutaraldehyde, formaldehyde,
neomycin, streptomycin and
polymyxin B which are used during the manufacturing process (see
section 4.3).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Suspension for injection.
Hexaxim is a whitish, cloudy suspension.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Hexaxim (DTaP-IPV-HB-Hib) is indicated for prima